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Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining

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ClinicalTrials.gov Identifier: NCT01863368
Recruitment Status : Completed
First Posted : May 27, 2013
Results First Posted : July 10, 2015
Last Update Posted : August 4, 2015
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Other: Preservative-free saline solution eyedrops Other: Systane® ULTRA lubricant eyedrops Other: OPTIVE® lubricating eyedrops Not Applicable

Detailed Description:
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Systane® ULTRA Compared to OPTIVE® in Ocular Surface Staining
Study Start Date : September 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Systane

Arms and Interventions
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Arm Intervention/treatment
Experimental: Systane Ultra
Systane® ULTRA lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
 Other: Preservative-free saline solution eyedrops
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.

Other: Systane® ULTRA lubricant eyedrops
Active Comparator: Optive
OPTIVE® lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
 Other: Preservative-free saline solution eyedrops
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.

Other: OPTIVE® lubricating eyedrops


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) [ Time Frame: Baseline, Day 35 ]
    The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.


Secondary Outcome Measures :
  1. Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) [ Time Frame: Day 35 ]
    The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.

  2. Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) [ Time Frame: Day 35 ]
    The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.

  3. Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) [ Time Frame: Day 35 ]
    The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to attend all study visits.
  • Diagnosis of dry eye, as specified in protocol.
  • Uses artificial tears, as specified in protocol.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Poor visual acuity, as specified in protocol.
  • Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol.
  • Any hypersensitivity or allergy to the investigational products or ingredients.
  • Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol.
  • Contact lens use within 2 weeks of Screening Visit.
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863368


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Steve Burmaster Alcon Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01863368    
Other Study ID Numbers: M-12-040
First Posted: May 27, 2013    Key Record Dates
Results First Posted: July 10, 2015
Last Update Posted: August 4, 2015
Last Verified: July 2015
Keywords provided by Alcon Research:
Dry eye syndrome
Systane Ultra
Optive
 Ocular Surface Staining
OSDI
Eye drops
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Pharmaceutical Solutions